{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,4,2]],"date-time":"2022-04-02T19:22:31Z","timestamp":1648927351026},"reference-count":15,"publisher":"Georg Thieme Verlag KG","issue":"02","license":[{"start":{"date-parts":[[2020,2,13]],"date-time":"2020-02-13T00:00:00Z","timestamp":1581552000000},"content-version":"vor","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Horm Metab Res"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:p>Dear Editor,<\/jats:p><jats:p>Drs. Kiaei and Molinaro 1 put forth two\n                    criticisms of the manuscript published by us 2. They state that the experimental design of this study is flawed\n                    and that the authors falsely claim that negative Thyretain\u2122 TSI Reporter\n                    BioAssay results for two Graves\u2019 diseases patients undergoing drug\n                    treatments means the absence of stimulating antibodies. To substantiate this\n                    claim Drs. Kiaei and Molinaro point out that the manufacturer of the Thyretain\n                    TSI Reporter BioAssay clearly states in the package insert that \u201c[t]he\n                    effects of various drug therapies on the performance of this Kit have not been\n                    established\u201d 1. Second, the\n                    package insert explicitly states that \u201c[a] negative result does not\n                    exclude the possibility of the presence of TSI\u201d and results of the test\n                    should be interpreted in conjunction with information available from other\n                    clinical information, such as physical symptoms and thyroid hormone testing, as\n                    recommended by the American Thyroid Association (ATA)\u201d. Furthermore they\n                    state that the \u201cauthors of the manuscript did not consider the\n                    manufacturer\u2019s warning regarding the intended patient population and the\n                    ATA guidelines regarding the interpretation of the test results in conjunction\n                    with other clinical information. Instead, the authors based their conclusions on\n                    the negative Thyretain TSI Reporter BioAssay results and ignored the\n                    patients\u2019 clinical history of Graves\u2019 disease.\u201d<\/jats:p>","DOI":"10.1055\/a-1089-8026","type":"journal-article","created":{"date-parts":[[2020,2,14]],"date-time":"2020-02-14T00:14:06Z","timestamp":1581639246000},"page":"126-127","source":"Crossref","is-referenced-by-count":0,"title":["Reply to Drs. Kiaei and Molinaro Regarding the Publication\n                    \u201cComparison of a Bridge Immunoassay with Two Bioassays for Thyrotropin Receptor\n                    Antibody Detection and Differentiation\u201d"],"prefix":"10.1055","volume":"52","author":[{"given":"Stephanie","family":"Allelein","sequence":"additional","affiliation":[{"name":"Medical Faculty, Division for Specific Endocrinology, University of\n                    D\u00fcsseldorf, D\u00fcsseldorf , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tanja","family":"Diana","sequence":"additional","affiliation":[{"name":"Department of Medicine I, Molecular Thyroid Research Laboratory,\n                    Johannes Gutenberg University (JGU) Medical Center, Mainz ,\n                    Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthias","family":"Schott","sequence":"additional","affiliation":[{"name":"Medical Faculty, Division for Specific Endocrinology, University of\n                    D\u00fcsseldorf, D\u00fcsseldorf , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George J.","family":"Kahaly","sequence":"additional","affiliation":[{"name":"Department of Medicine I, Molecular Thyroid Research Laboratory,\n                    Johannes Gutenberg University (JGU) Medical Center, Mainz ,\n                    Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2020,2,13]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"124","DOI":"10.1055\/a-1089-7906","article-title":"A Negative Thyretain TSI bioassay result does not exclude the possibility of the\n                    presence of TSI","volume":"52","author":"D Kiaei","year":"2020","journal-title":"Horm Metab Res"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1055\/a-0914-0535","article-title":"Comparison of a bridge immunoassay with two bioassays for thyrotropin receptor\n                    antibody detection and differentiation","volume":"51","author":"S Allelein","year":"2019","journal-title":"Horm Metab Res"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1309\/AJCPZUT7CNUEU7OP","article-title":"Analytical performance and clinical utility of a bioassay for\n                    thyroid-stimulating immunoglobulins","volume":"139","author":"J J Leschik","year":"2013","journal-title":"Am J Clin Pathol"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"1998","DOI":"10.1210\/jc.2016-1220","article-title":"Thyroid stimulating antibodies are highly prevalent in hashimoto\u0313s thyroiditis\n                    and associated orbitopathy","volume":"101","author":"G J Kahaly","year":"2016","journal-title":"J Clin Endocrinol Metab"},{"key":"ref5","doi-asserted-by":"crossref","first-page":"2561","DOI":"10.1210\/jc.2018-02705","article-title":"High titers of thyrotropin receptor antibodies are associated with orbitopathy\n                    in patients with graves disease","volume":"104","author":"G J Kahaly","year":"2019","journal-title":"J Clin Endocrinol Metab"},{"key":"ref6","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1007\/BF03348154","article-title":"Detection and characterization of autoantibodies blocking the TSH-dependent cAMP\n                    production using FRTL-5 cells","volume":"10","author":"L Chiovato","year":"1987","journal-title":"J Endocrinol Invest"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1089\/thy.2012.0374","article-title":"Thyrotropin-blocking autoantibodies and thyroid-stimulating autoantibodies:\n                    potential mechanisms involved in the pendulum swinging from hypothyroidism to\n                    hyperthyroidism or vice versa","volume":"23","author":"S M McLachlan","year":"2013","journal-title":"Thyroid"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1111\/cei.12129","article-title":"A novel bioassay for anti-thyrotrophin receptor autoantibodies detects both\n                    thyroid-blocking and stimulating activity","volume":"173","author":"Y Li","year":"2013","journal-title":"Clin Exp Immunol"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"734","DOI":"10.1089\/thy.2015.0447","article-title":"Analytical performance and validation of a bioassay for thyroid-blocking\n                    antibodies","volume":"26","author":"T Diana","year":"2016","journal-title":"Thyroid"},{"key":"ref10","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1111\/cei.12980","article-title":"Prevalence and clinical relevance of thyroid stimulating hormone\n                    receptor-blocking antibodies in autoimmune thyroid disease","volume":"189","author":"T Diana","year":"2017","journal-title":"Clin Exp Immunol"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"853","DOI":"10.1055\/a-0723-9023","article-title":"Thyrotropin receptor blocking antibodies","volume":"50","author":"T Diana","year":"2018","journal-title":"Horm Metab Res"},{"key":"ref12","doi-asserted-by":"crossref","first-page":"243","DOI":"10.1159\/000478522","article-title":"Performance and specificity of 6 immunoassays for TSH receptor antibodies: a\n                    Multicenter Study","volume":"6","author":"T Diana","year":"2017","journal-title":"Eur Thyroid J"},{"key":"ref13","doi-asserted-by":"crossref","first-page":"438","DOI":"10.1111\/j.1365-2249.2010.04266.x","article-title":"Novel chimeric thyroid-stimulating hormone-receptor bioassay for\n                    thyroid-stimulating immunoglobulins","volume":"162","author":"S D Lytton","year":"2010","journal-title":"Clin Exp Immunol"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"880","DOI":"10.1055\/s-0035-1554662","article-title":"Bridge technology with TSH receptor chimera for sensitive direct detection of\n                    TSH receptor antibodies causing graves\u2019 disease: analytical and clinical\n                    evaluation","volume":"47","author":"C U Frank","year":"2015","journal-title":"Horm Metab Res"},{"key":"ref15","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1007\/s40618-016-0478-9","article-title":"Highly variable sensitivity of five binding and two bio-assays for TSH-receptor\n                    antibodies","volume":"39","author":"T Diana","year":"2016","journal-title":"J Endocrinol Invest"}],"container-title":["Hormone and Metabolic 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